QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS

FDA premarket approval P030054/S291 · decided 2016-02-12

Approval details

PMA number

P030054

Supplement

S291

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS

Generic name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Applicant

ABBOTT MEDICAL

Date received

2015-08-17

Decision date

2016-02-12

Days to decision

179 days

Decision code

APPR

Product code

NIK

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

Approval for Quadra Assura MP Cardiac Resynchronization Therapy devices (CRT-Ds) Models CD3269-40, CD3269-40Q, CD3369-40, CD3369-40Q, CD3369-40C, CD3369- 40QC; Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker devices (CRT-Ps) Models PM3160 and PM3262; and Model 3330 Version 21.1 Software for the Model 3650 Merlin Patient Care System Programmer.

510(k) clearances by this applicant